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Study of Time to Pregnancy in Normal Fertility

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ClinicalTrials.gov Identifier: NCT00161395
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 16, 2008
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

Condition or disease Intervention/treatment Phase
Fertility Pregnancy Behavioral: Instruction in the Creighton Model Fertility Care System Behavioral: Preconception advice Phase 2

Detailed Description:

Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.

All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.

All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.

The primary outcome is time to pregnancy.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility
Study Start Date : January 2003
Primary Completion Date : August 2006
Study Completion Date : March 2007
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Preconception advice.
Behavioral: Preconception advice
Preconception advice for diet and frequency of intercourse.
Experimental: 2
Instruction in the Creighton Model Fertility Care System.
Behavioral: Instruction in the Creighton Model Fertility Care System
Instruction in the Creighton Model Fertility Care System.
Other Name: Fertility awareness instruction.

Outcome Measures

Primary Outcome Measures :
  1. Time to Pregnancy [ Time Frame: Up to one year. ]

Secondary Outcome Measures :
  1. Distribution of coitus within "fertile" days of menstrual cycle [ Time Frame: Seven menstrual cycles. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • couple with prior pregnancy within the past 8 years

Exclusion Criteria:

  • any history that suggests subfertility
  • any history that suggests a medical contraindication for pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161395

United States, Utah
University of Utah, Dept. Family and Preventive Medicine
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Joseph B Stanford, MD University of Utah
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Stanford, M.D., Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00161395     History of Changes
Other Study ID Numbers: K23HD001479 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: September 2005

Keywords provided by University of Utah: